Lorazepam for the Treatment of Status Epilepticus in Children
Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Status Epilepticus
Intervention: lorazepam (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s): James Chamberlain, MD, Principal Investigator, Affiliation: Children's National Medical Center, Washington, D.C.
Summary
The purpose of this study is to gather the data to: 1) determine the best dose, and 2)
evaluate its effectiveness and safety in stopping seizures. Part 1 is a pharmacokinetic
study (study of how much drug is found in the body after it is given through a vein and how
fast the body gets rid of the drug).
Clinical Details
Official title: Use of Lorazepam for the Treatment of Status Epilepticus
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam
Secondary outcome: safety of IV lorazepam
Detailed description:
Lorazepam is in a class of drugs called benzodiazepines that is used to treat seizures.
Lorazepam has been widely used to treat children who have repeated or long seizures, a
condition known as status epilepticus (SE). However, lorazepam is not currently approved by
the FDA for use in children under 18 years of age. Therefore, the purpose of this study is
to gather the data needed for FDA approval. Specifically, we will 1) determine the best
dose, and 2) evaluate its effectiveness and safety in stopping seizures. Part 1 is a
pharmacokinetic study. These are studies designed to identify and describe one or more of
the following basic pharmacological concepts in humans: absorption (i. e. how much gets into
the body); distribution (i. e. where it goes in the body); and metabolism and elimination
(i. e. how the body gets rid of the medication and how long it takes). The study procedures
involve taking blood samples from children, taking their vital signs, and conducting
physical examinations. Informed consent will be obtained from all participants as required
by federal guidelines. Patients will be divided into two groups. The first group will be
patients who present to one of the 10 participating Emergency Rooms (ERs) in status
epilepticus (repeated or continuous seizures). We will either ask for consent in the ER, or
if we know they have a seizure disorder and have frequent visits to the ER, consent them
beforehand for future visits to the ER. The second group will include patients who have a
known seizure disorder and agree to be electively admitted to the hospital for a dose of
lorazepam when they are not having seizures. We will draw blood samples from patients for up
to 48 hours and then follow up via telephone for 30 days from the day the medication was
given to assess for side effects.
Eligibility
Minimum age: 3 Months.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Generalized tonic clonic seizures within 1 hour OR 2 or more generalized tonic clonic
seizures in rapid succession with no recovery of consciousness between seizures OR a
single ongoing generalized tonic clonic seizure which has lasted at least 5 minutes
Exclusion Criteria:
- Inability to obtain informed consent or assent
- Sustained hypotension
- Significant arrhythmia
- Known hypersensitivity to or contraindication to use of benzodiazepines
- Use of lorazepam within 4 days of study drug dosing
- American Association of Anesthesiology (ASA) Class > 1
Locations and Contacts
Children's National Medical Center, Washington, District of Columbia 20010, United States
Additional Information
Starting date: March 2005
Last updated: February 13, 2011
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